Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Vancomycin hydrochloride
Sandoz Ltd
J01XA01
Vancomycin hydrochloride
500mg
Powder for solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010700
VANCOMYCIN, 500 MG, POWDER FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 22-May-2015 | Sandoz Limited 1. Name of the medicinal product Vancomycin, 500 mg, powder for solution for infusion 2. Qualitative and quantitative composition Each vial contains 500 mg vancomycin (hydrochloride) equivalent to 500,000 IU. 3. Pharmaceutical form Powder for solution for infusion. White or almost white powder. After reconstitution a solution is obtained with a pH of approximately 3. 4. Clinical particulars 4.1 Therapeutic indications Vancomycin solution, used intravenously is indicated in the therapy of severe, potentially life-threatening infections due to susceptible gram-positive microorganisms which cannot be treated with or failed to respond to other effective, less toxic antimicrobial medicinal products, such as penicillins and cephalosporins. Vancomycin should be reserved for those cases where there is a specific indication, to minimize the chance of resistance emerging. Vancomycin is useful in the treatment of the following severe infections caused by susceptible microorganisms (see section 5.1): - endocarditis, - infections of bones (osteomyelitis), - pneumonia, - soft-tissue infections. Endocarditis caused by enterococci, _Streptococcus viridans_ or _S. bovis_ should be treated with a combination of vancomycin and an aminoglycoside. Vancomycin may be used for the perioperative prophylaxis against bacterial endocarditis, in patients at high risk of developing bacterial endocarditis when they undergo major surgical procedures (e.g., cardiac and vascular procedures, etc) and are unable to receive a suitable beta-lactam antibacterial agent. _CONSIDERATION SHOULD BE GIVEN TO OFFICIAL GUIDANCE ON THE APPROPRIATE USE OF ANTIBACTERIAL AGENTS._ 4.2 Posology and method of administration _Vancomycin powder for solution for infusion must be administered intravenously. Each dose should be _ _administered at a rate not exceeding 10 mg/min or over a period of time of at least 60 minutes (whichever_ _is longer). Read the complete document